FDA Product Code JZO: System, Test, Thyroid Autoantibody

FDA product code JZO covers thyroid autoantibody test systems used in the diagnosis of autoimmune thyroid diseases.

These immunoassays detect antibodies against thyroid peroxidase (TPO), thyroglobulin, or TSH receptors in serum, enabling the diagnosis of Hashimoto's thyroiditis, Graves' disease, and other autoimmune thyroid conditions.

JZO devices are Class II medical devices, regulated under 21 CFR 866.5870 and reviewed by the FDA Immunology panel.

Leading manufacturers include American Laboratory Products Co., Ltd., Roche Diagnostics Corp. and Elias U.S.A., Inc..